DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Receipt and entry of the response dated 10/10/2025 is acknowledged.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application Nos. 14/976,321; 15/143,981; 15/853,821 and 16/004,401 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The parent applications do not support at least the following features recited by claim 1: treating and imaging using “compressive non-thermal low power focused ultrasound” and “exciting the … nanoparticles … in a first compressive, non-thermal, low power focused mode using an ultrasound source [...] so as to peel off the polymer coating of the nanoparticles … by the focused vibration of the ultrasonic wave, thereby releasing the dye or indicator into the circulation of the patient.”
Therefore, the earliest priority date to which instant claims 1-4, 8, 9, 11-13 are entitled is 26 October 2017, which is the earliest provisional application supporting the claimed combination under examination (provisional App. No. 62/577,485). While this is linked via PCT/US2018/054880, to which the instant application also relates as continuation-in-part, the claimed subject matter is equally supported in at least the claims of the PCT.
Terminal Disclaimer
The terminal disclaimer filed on 10/10/2025 and disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 11,433,260 and US 11,090,385 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 8, 9, 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Peyman (US 2016/0022976, of record) in view of Jin et al. (US 2010/0303716, of record).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Peyman in view of Jin et al., as applied to claim 1, and further in view of Xin et al. (Transl Androl Urol. 2016 Apr; of record).
These rejections are maintained for reasons made of record in the Office Action dated 5/19/2025 and for reasons set forth below.
Claim 1 has been amended to include the limitations of claim 3, previously included in this rejection.
Response to Arguments
Applicant's arguments filed 10/20/2025 have been fully considered but they are not persuasive. Applicants essentially assert that the amendments to claim 1 are not taught by Peyman and Jin et al. Such is not convincing. Peyman the ultrasound operational parameters in cited ¶[0099]-[0100], the claimed effects of damaging tumor cell membranes with temperature increases in ¶ [0051] and the melting effect of the polymer coating in ¶ [0216]. Jin et al teach alternating heating with vibration in ¶’s [0076]-[0077]. Peyman and Jin et al teach ultrasonic frequency ranges which overlap with the range claimed in claim 4 that achieves the heating effect. See at least Peyman at ¶ [0201] and Jin at ¶ [0084]. The claim limitation of “…so as to avoid damaging normal tissue of the patient…” is not a specific, active method step but an intended result. It is considered that practicing the ultrasound methods of Peyman and Jin et al would achieve this same result inherently as the method steps are the same.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Peyman in view of Jin et al., as applied to claim 1, as evidenced by Kruse et al. (IEEE Trans Biomed Eng. 2010 Jan; of record). This rejection is maintained for reasons made of record in the Office Action dated 5/19/2025 and for reasons set forth below.
Response to Arguments
Applicant's arguments filed 10/20/2025 have been fully considered but they are not persuasive. Applicants essentially assert that the passages cited from Kruse et al is insufficient to teach the claimed power range. Such is not convincing. The rejection does not rely on Kruse alone, as Peyman and Jin et al teach ultrasound frequencies which overlap with the thermal frequencies claimed. See at least Peyman at ¶[0201] and Jin at ¶[0084]. Combined with the teachings of Kruse et al of average power delivered over an area is predictive of the heating, suggesting to those skilled in the art that the average power of ultrasound delivered for the disclosed targeted temperature in Peyman would necessarily require operating the ultrasound transducer(s) at a power on the order of the range claimed.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MICHAEL D BURKHART/Primary Examiner, Art Unit 1638